Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT06141265
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Study Details

This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.

Key Dates

Start date
Nov 1, 2023
Status verified
Nov 2023
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Primary Outcome Measure

Progression Free Survival (PFS) Rate at 24 months (PFS24) [ Time Frame: At 24 months ]

Central Contacts